Study to Determine the Effectiveness of Risperidone in Bipolar Disorder in Children and Adolescents

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A clinical study to determine the safety and effectiveness of risperidone compared with placebo in the treatment of bipolar disorder (manic or mixed type) in children and adolescents aged 10 to 17 years.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• Current primary diagnosis of bipolar I disorder, mania or mixed type

• Aged between 10 and 17 years

• Young Mania Rating Scale score greater than or equal to 20 at screening and baseline

Exclusion Criteria:

• Known or suspected history of substance dependence

• Significant risk for suicidal or violent behavior

• Received electroconvulsive treatment within 4 weeks of baseline

• Received a depot antipsychotic within 2 treatment cycle before baseline

• Is unable to swallow medication taken in the form of tablets

• Has a positive result for a urine drug screen done at baseline

• Known or suspected seizure disorder

• Hypothyroidism or hyperthyroidism, unless stabilized on appropriate medication for at least 3 months before screening

• Known or suspected history of hypersensitivity or intolerance to risperidone

• History of a poor antimanic response to risperidone when used in adequate doses for an adequate period as the sole antimanic agent